WO2013155002A1 - Système de télémédecine sans fil - Google Patents

Système de télémédecine sans fil Download PDF

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Publication number
WO2013155002A1
WO2013155002A1 PCT/US2013/035644 US2013035644W WO2013155002A1 WO 2013155002 A1 WO2013155002 A1 WO 2013155002A1 US 2013035644 W US2013035644 W US 2013035644W WO 2013155002 A1 WO2013155002 A1 WO 2013155002A1
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WO
WIPO (PCT)
Prior art keywords
examination
medical
patient
location
data
Prior art date
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PCT/US2013/035644
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English (en)
Inventor
Richard Franz
John Weber
Original Assignee
Richard Franz
John Weber
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Richard Franz, John Weber filed Critical Richard Franz
Publication of WO2013155002A1 publication Critical patent/WO2013155002A1/fr

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    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/10—Office automation; Time management
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H30/00—ICT specially adapted for the handling or processing of medical images
    • G16H30/20—ICT specially adapted for the handling or processing of medical images for handling medical images, e.g. DICOM, HL7 or PACS
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems

Definitions

  • the present invention relates to the use of wireless data acquisition and transmission devices to conduct medical examinations, transfer patient examination information to a remote location, obtained an professional opinion regarding the patient's health using such information, and providing the patient with a real-time professional opinion based on such information.
  • Certain aspects of the invention involve systems and methods for conducting a medical examination at a first location comprising the use of one or more medical examination devices (which devices may include one or more multifunctional device capable of performing multiple different tests) to convey patient medical data to a wireless telecommunication device (or be part of the device) ; the acquired patient examination data may then be transmitted to a diagnostic center at a second location at which a medical services professional can review the patient examination data and provide a professional opinion to the patient or medical professional, preferably in "real-time"; that is, for example, before the patient leaves the first location, or by e-mail, text or other telecommunication device.
  • wireless any available means for transmitting and/or receiving data (e.g., digital or analog data) without an electrical connection, such as a cable or wire.
  • the term thus, without limitation, includes devices having a transmitter and/or a receiver capable, respectively, of transmitting or receiving data by employing one or more wavelength or ranges of wavelengths of the electromagnetic spectrum, such as infrared, visible light, ultraviolet, microwave, and radio waves, magnetic flux, laser or focused beams, etc.
  • Other methods may include, without limitation, acoustic detection, optical and radioactive methods, and sound.
  • computing/telecommunications devices including "smartphones", such as Apple's iPhone® smartphone, Google's Android®
  • the iPhone® in particular, has revolutionized the smartphone field, permitting the acquisition and sharing of photographs (including "scanned” images) , video, Internet webpage images, and the like; virtually every wireless
  • Wireless e.g., modem-based communications using, for example, laptop computers running self-contained software applications had already been available for a decade or so before the advent of the iPhone®; however these devices generally were of limited use without a relatively constant electrical supply, due to their considerable power requirements and limited rechargeable battery life.
  • the iPad® and its progeny typically do not contain a telephone, but communicate over digital telecommunications lines shared with access to the Internet.
  • the iPad® may contain a camera, such as a video camera, which permits face-to-face conversations between users over WiFi using the Internet. Additionally, the iPad®, uses smaller versions of certain personal computer software
  • so-called “cloud” computing permits computationally intensive activities to occur at a server that may house the application, while permitting data entry and result reporting to occur at the user's workstation or device.
  • a server or "server farm” may house the majority of the applications used by employees; in this case, relatively unsophisticated computing devices are required at each employees workstation, since most of what is required of such devices is to provided the input, and to retrieve
  • Telemedicine The use of telecommunications in the medical field has created an array of various technologies, and systems, broadly termed "telemedicine” . Telemedicine systems for performing vision testing and eye examination are described in U.S. Patent Nos. 4,761,071; 5,617,157; 5,694,199; 5,912,720; 5,943,116; 5,993,001; 6,003,991; 6,022,315; 6,027,217; and 6, 033, 076.
  • United States Patent Publication No. 2001/0279718 discloses systems, devices, and methods for communicating medical information using a mobile telephone with a digital camera.
  • MMS Multimedia Messaging Service
  • hub in wireless communication with a medical sensor device, wherein the hub includes a data repository system and an interactive voice response (IVR) system, wherein the patient receives a set of instructions from the IVR by telephone which prompts the patient to self-administer a collection of a set of physiological data with the medical sensor device and requires the patient to confirm each of a plurality of steps in set of instructions with the user interface for the telephone .
  • IVR interactive voice response
  • United States Patent Publication No. 2006/0036134 discusses a telemedicine system for monitoring chronic conditions such as asthma or diabetes.
  • the system includes an electronic measurement device such as electronic peak expiratory flow meter or an electronic blood glucose meter connected to a cellular telephone.
  • the cellular telephone automatically receives, formats, and transmits the data on acquisition by the medical device to a remote server.
  • the server may acknowledge the data and make the data
  • United States Patent No. 5,987,519 (Peifer et al . ) is drawn to a packet-based telemedicine system for communicating video, voice and medical data between a central monitoring station and a patient monitoring system, which is remotely located with respect to the central monitoring station.
  • the patient monitoring station obtains digital video, voice and medical measurement data from the patient and encapsulates the data in packets, sending the packets over a network to the central monitoring station.
  • United States Patent Publication No. 2008/0146276 discloses a mobile phone with a stethoscopic function.
  • the stethoscope microphone may be either intricately built into the cellular phone, or an exterior stethoscopic
  • United States Patent Publication No. 2009/0088607 (Muraca) , is drawn to a remote disease management system, method, and computer-readable medium including a patient's cell phone acquiring medical data and automatically
  • the data may be acquired wirelessly or by manual input from remote sensors acquiring medical information about the patient.
  • the patient's cell phone receives a text message from a physician
  • United States Patent No. 7,942,526 discloses a macular health measurement and storage system comprising a plurality of macular-pigment measurement machines for measuring macular pigment density and humans, a plurality of computers each of which is associated with a corresponding one of such machines, and a central host.
  • computers includes a second port for transferring patient data .
  • United States Patent Publication No. 2008/0259274 discloses a handheld digital camera for obtaining images of a portion of a patient's body and having a handheld housing, of visible light source located within the housing for providing light, an image sensor that detects light returning from the patient's body along an imaging path that passes into the housing of the aperture, an output display carried by the housing, and the ability to electronically transmits stored images.
  • the information configured to examine a patient's eye, and a controller for collecting and transmitting the examination data of the patient's eye.
  • the diagnostic center furthermore, a communications link to a diagnostic center for analyzing the information collected at the remote exam module.
  • the diagnostic center further
  • a processor includes receiving, by a processor, information from a person via a research tool related to one or more health issues of the person; generating a medical case based on the information received from the person; calculating one or more likelihoods associated with one or more potential causes of the health issues; determining whether the likelihoods indicate that the medical case is "complex"; and when the medical case is complex, granting the person access to collaboration module.
  • a multi functional mobile phone performs hearing and vision tests through a built-in or externally connected device monitor, measures and collects data of body and environmental temperature, heart beat, long respiration, cardiac and pulmonary house chelation, sugar level, blood pressure, etc., takes body photo images for the clinical assessment, displays and plays back instructions to conduct the diagnostic test and rehabilitation treatments, stores and updates programs for the tests and treatments and communicates with a remote medical specialist using a mobile phone network.
  • United States Patent Publication No. 2011/0015496 (Sherman et al . ) is drawn to a portable medical device
  • sensors for connection to a smartphone being configured to collect medical information relating to patient, and an interface coupled to the sensor and configured to communicate the collected medical data from the patient to the mobile communication device.
  • Such systems may include an integrated, wireless- based telemedicine system, and associated methods of using such a system, that is able to convey data from at least a plurality of medical examination devices (either as separate devices or as one or more multifunctional device) to a
  • the medical examination device or devices may be part of such a wireless telecommunications device, either as an integrated part (which may include a software program contained on such device) or as an attachment wherein the medical examination devices comprise at least one, and preferably a plurality of inexpensive attachments to such a wireless communication device.
  • the system preferably enables a person to conduct a medical examination of a patient using a wireless
  • the system also preferably enables, a professional opinion to be transmitted back to the patient or to a medical
  • telecommunication device capable or receiving and displaying the opinion and associated data, such as e-mail, text
  • real time is meant within a period of time, reasonable under the circumstances, within which the patient would be expected to be able to remain at or within close proximity to the medical examination site, the telecommunication device. Although in very remote locations, real-time may be within about 36 hours, or about 36 hours or less, in most cases it would helpful if the
  • the present invention is related to improved methods and systems for providing medical diagnostic services.
  • the invention is related to improved methods and systems for providing medical services to patients in remote locations through the use of wireless communication and/or computing devices.
  • patients typically (although not invariably) lack convenient access to medical professionals due to distance, age, infirmity, or lack of financial resources.
  • the methods and systems of the present invention comprise the use of wireless telecommunications to provide sufficient patient examination data from a remote location to a medical
  • the systems and methods of the present invention provide for the use of wireless telecommunications to communicate a professional opinion back to the patient before the patient has left the vicinity of the remote patient examination location.
  • a “medical professional” is defined herein to mean either a licensed medical professional, such as a physician,
  • physician's assistant registered nurse, nurse practitioner, or the like; or an unlicensed medical professional such as an optician or midwife.
  • a “diagnostic center” is defined as a location different (or “remote") from a patient examination location containing one or more digital communication device capable of receiving transmitted medical examination data, permitting a medical professional receiving such transmitted medical examination data to be capable of providing a professional opinion (such as, without limitation, a prescription or diagnosis) based thereupon.
  • a diagnostic center may comprise a different room from, or location within the same building as, a patient examination location.
  • a diagnostic location may exclude a
  • the diagnostic location may comprise locations at least a distance of one mile or more from the examination location: for
  • a second location "remote" from the first location may comprise a different room from, or location within the same building as the first location.
  • a remote location may be other than a different room or location within the same building from the first location.
  • the remote location may be at least a distance of one mile or more from the first location: for example, at least 5 miles, or at least 10 miles, or at least 25 miles, or at least 50 miles, or at least 70 miles, or at least 100 miles or more from the first location.
  • the present invention involves the use of wireless data
  • diagnostic devices functionally linked to a wireless, portable, telecommunications device, to collect patient examination data in a first location and to transfer the patient information, either as raw data or as formatted data, to a second location remote from the first location.
  • the present invention permits the collection of patient examination data from a patient located at an examination site and the wireless transmission of such data, either raw or processed (for example, compiled into a database, or otherwise manipulated using an algorithm) , to a diagnostic center at a location remote from such patient examination site in a manner that is sufficiently inexpensive, fast and comprehensive to permit a medical professional at the remote location to provide a medically competent professional opinion, preferably in real time, and even more preferably before the patient leaves the patient examination site.
  • a “medical examination device” or “diagnostic device” may be capable of performing more than one medical test.
  • a single diagnostic device may comprise at least two of an autorefractor, a keratometer and a non-contact tomometer which are able to perform different tests.
  • an autorefractor a keratometer
  • a non-contact tomometer which are able to perform different tests.
  • the system may include the direct or indirect wireless transmission of patient examination data to a database, or central computing site at a remote location that employs algorithms and sophisticated software programs to automatically compare the patient examination data to a database of substantially similar data collected from a plurality of other patients, as well as to previous
  • This latter comparison data may then be used by a medical professional to provide patient specific recommendations, information, and a
  • the database or central computing center is part of a "cloud computing" network that receives input date wirelessly from a wireless, portable, telecommunications device and sends computational results wirelessly to the patient examination site, the diagnostic site, or both.
  • a central computing center or cloud computing network may utilize more than one server or other processor, and may be located at more than one physical site remote from the patient examination site.
  • the database or central computing site may be at a location remote from either the patient examination location or the diagnostic center.
  • the database or central computing site, or a component thereof may be located at the same location as the diagnostic center.
  • a “wireless telecommunications device” means a device such as a wireless cellular or satellite telephone capable of transmitting data (such as through a modem) , or a wireless mobile computing device such as, without limitation, a smartphone, a laptop computer, a personal digital assistant (PDA) , a tablet computing device (such as, for example, an iPad®-type device) , or a visual display device (such as
  • the wireless portable telecommunications device may have a minimum of
  • microprocesssing ability itself, and will function mainly as a means for wirelessly transmitting the collected data to a central computing site or cloud network.
  • one or more medical data acquisition tool is comprised as part of a WTD.
  • WTDs are configured and structured to operate software programs that are typically downloaded from the Internet, although they may be installed on the devices when they are purchased. These software programs, termed
  • the WTDs generally have operating system programs through which the other apps may work.
  • the WTD is a general purpose wireless telecommunications device.
  • general purpose is meant that the basic WTD hardware and software is manufactured and sold to the general (non-medical professional) public and is not specially fabricated for use in a medical field. Examples may include common smartphones and tablet computing devices. Although the basic hardware and software of a general purpose WTD is not specialized, a general purpose WTD may optionally comprise downloadable apps, attachments, devices (such as diagnostic sensors or devices) , and connectors; these may in certain cases be specialized to be used in concert with the WTD.
  • the presently claimed invention employs WTDs having 1 or more, or 2 or more, or 3 or more medical
  • the WTD itself comprises at least part of the device.
  • at least partly integrated is meant that the WTD (without hardware
  • WTD apps comprises at least an element of the 1 or more, or 2 or more, or 3 or more sensors or devices. This would be the case, for example, where a diagnostic device or sensor comprises a WTD' s still or video camera function, pressure- or heat-sensitive screen function, eye location software function or the WTD comprises a diagnostic device software app .
  • WTD apps may be directed to medical uses. Also, a variety of smartphone and/or tablet apps have become available for use by medical students, patients, and medical
  • Various data and imaging applications are available for sharing data between mobile devices and a central computer center, computer network (such as a hospital network) , or cloud network.
  • the Mobile MIMMTM application permits physicians to have mobile access via smartphone or tablet device to x-ray and ultrasound images, and to share the images with peers.
  • smartphone apps are available for physician remote monitoring of patient cardiology devices, vital sign monitoring, and OB/Gyn functions in real time.
  • the United States Patent and Trademark Office granted Apple an iPhone®-related patent that covers wireless remote monitoring of a patient's vital signs.
  • diagnostic data or “examination data” is meant data collected from a patient being tested for the presence or absence of one or more medical condition; such data may, and preferably does, exclude routine monitoring data; in other words, data resulting from the regular or frequent monitoring of basic vital signs over a period of time (for example, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours or more) from a patient having a chronic medical condition.
  • IPhone® related applications also been coupled with iPhone® attachments, some of them costing less than about $30 to produce, for conducting the diagnosis and analysis of potential refractive error in the lens of the eye. According to the world health organization, uncorrected refractive errors or the world's second-highest cause of blindness; all these people are potentially beneficiaries of such
  • MIT Massachusetts Institute of Technology
  • Slit lamps are instruments consisting of a intense light source that can be focused to shine a thin sheet of light into the eye to examine features of the cornea, conjunctiva, lens, iris and sclera of the eye, and can detect and help form an attenuation map of the lens showing the presence of early onset cataracts;
  • the inverse Shack-Hartmann wavefront sensor attachment involves a display set at very close range to the human eye.
  • the laser which is usually shined into the eye of the patient is replaced by user interaction in which the subject looks into a display and aligns patterns which pass through different visual regions, thus giving a measure of optical distortions and also myopia, hyperopia, and
  • smartphone attachments comprising two or more integrated diagnostic devices, or dedicated WTDs for medical use that include examination devices for conducting medical
  • Fig. 1 provides an example of a wireless
  • telecommunication system of the present invention in which a patient's refractive error is tested at an examination location and the results wirelessly transmitted to a
  • diagnostic center at a location remote from the examination location .
  • Fig. 2 provides an example of a wireless
  • telecommunication system of the present invention in which a medical patient's data is collected at an examination location and then processed according to a software-based diagnostic algorithm at a central computing center. The prospective professional opinion is then provided to a medical
  • Fig. 3 is a diagram showing an example of a basic algorithm of the type that may be used to process patient examination data for presentation to the medical professional and/or patient.
  • the present invention is drawn to a mobile wireless telecommunication device (WTD) , for example (but not limited to) a smartphone, laptop computer, "smart” eyewear (such as the "Google® glass” computing
  • an aspect of the present invention concerns a system for conducting a medical examination from a medical examination location, comprising: a plurality of medical examination devices located at a first medical examination location; a wireless telecommunication device located at said first medical examination location and configured to directly receive diagnostic patient examination data from two or more of the medical examination devices, said wireless
  • telecommunication device configured to transmit the diagnostic data via a wireless communications link to a second location remote from said first medical examination location; a diagnostic center situated in said second remote location and capable of receiving transmitted diagnostic data from said medical examination location to enable the diagnosis of a medical disorder or disease of the patient by a medical professional, thus permitting the medical professional to provide a professional opinion based on the patient's
  • a medical examination device may be comprised (at least partially integrated) as part of the wireless
  • the still or video camera component of a WTD may be comprised in the medical examination device.
  • the medical examination device may comprise the touchscreen of, a software app of, or an attachment to the wireless telecommunication device.
  • the medical examination device may comprise a
  • telecommunication device by operably plugging into a data port of the WTD, thereby routing the acquired data to the
  • the medical examination device may be distinct from, but functionally attached to, the WTD.
  • the medical examination device may comprise a data output port, which may be linked via a cable to the data input port of the WTD, thereby permitting the uploading of data to the
  • microprocessor ( s ) of the WTD microprocessor ( s ) of the WTD.
  • the medical examination may in some cases be any medical examination appropriate to the diagnosis of a medical
  • a patient may be examined for the presence, absence, or progress of diabetes; this may be accomplished by, for example and without limitation, examining the patient using one or more of medical examination devices selected from the group consisting of a blood glucose detection device, a blood pressure detecting device, a blood cholesterol detection device, a blood low density lipoprotein (LDL) detection device, a neural diagnosis device, a
  • medical examination devices selected from the group consisting of a blood glucose detection device, a blood pressure detecting device, a blood cholesterol detection device, a blood low density lipoprotein (LDL) detection device, a neural diagnosis device, a
  • pupilometer a scanning laser ophthalmoscope, blood high density lipoprotein (HDL) detection device, optical coherence tomographer (OCT) device, a blood triglyceride detection device, a visual fields testing device, a fundus camera, a retinal imaging device, a posterior segment imaging device; a urine glucose testing device, and the like.
  • HDL blood high density lipoprotein
  • OCT optical coherence tomographer
  • the professional may reasonably provide a competent professional opinion based on patient diagnostic data received from one or more such medical examination device.
  • the patient may be examined using two or more, or three or more or four or more such medical examination device.
  • the invention is directed to a system for conducting an eye examination from a remote location, comprising : a plurality of eye examination devices located at an eye examination location; a general purpose wireless telecommunication device (WTD) having one or more said eye examination devices at least partially integrated therein; said WTD being located at said eye examination location and configured to acquire diagnostic patient examination data from two or more of the eye examination devices, said diagnostic patient examination data being sufficient to permit a medical professional to render a professional opinion, said WTD configured to transmit the patient examination data via a wireless communications link to a location remote from said eye examination location; a diagnostic center situated in said remote location and capable of directly or indirectly receiving the diagnostic eye examination data from said eye examination location to enable a medical professional to render a professional opinion based thereupon, wherein said medical professional is located at the diagnostic center, thus permitting the eye care practitioner to provide a professional opinion based at least in part on the eye examination data, thus advising to the patient in real time, and wherein said diagnostic eye examination data does not comprise routine monitoring data.
  • WTD wireless telecommunication
  • the system may comprise the system described immediately above wherein an eye examination device at least partially integrated in said general purpose WTD comprises a specialized software application loaded therein.
  • the eye examination device comprises a camera integrated as part of said general purpose WTD.
  • the invention is directed to a system for conducting a diagnostic medical examination from a remote location, comprising: a plurality of medical examination devices located at an medical examination location, one or more said medical examination devices being at least partially integrated as part of a general purpose wireless telecommunication device (WTD) located at said medical examination location and configured to receive patient examination data from two or more of the medical examination devices, said WTD configured to transmit patient examination data via a wireless communications link to a location remote from said examination location; a diagnostic center situated in said remote location and capable of receiving the wireless transmitted patient examination data from said examination location to enable a medical professional located at the diagnostic center to provide a professional opinion, thus advising to the patient concerning the presence or absence of a medical disorder or disease based at least in part upon said patient examination data in real time, and wherein said patient examination data does not comprise routine patient monitoring data.
  • WTD wireless telecommunication device
  • the invention is directed to a system for conducting a medical examination from a remote location, comprising : a plurality of medical examination devices located at a medical examination location, one or more said medical examination devices being at least partially integrated as part of a general purpose wireless telecommunication device (WTD) located at said medical examination location and configured to receive patient examination data from two or more of the medical examination devices, said WTD configured to transmit patient examination data via a wireless communications link to a location remote from said examination location; a diagnostic center situated in said remote location having a automated clinical decision support system (CDSS) comprising a algorithm which receives said patient examination data as input and calculates a preliminary diagnosis as output, said output being made available to a medical professional—to enable said medical professional to assess the preliminary diagnosis and return a professional opinion using a wireless communications link to said medical examination location, thus advising to the patient concerning the presence or absence of a medical disorder or disease based at least in part upon said patient examination data in real time.
  • CDSS automated clinical decision support system
  • the invention is directed to a telemedicine system for conducting an eye examination at a location remote from a diagnostic center at which a medical professional is located comprising: a plurality of eye examination devices located at a first eye examination location; a wireless telecommunication device located at said first eye examination location and configured to directly receive patient eye examination data from two or more of the eye examination devices, said wireless telecommunication device configured to transmit the eye examination data via a wireless communications link to a second location remote from said first eye examination location; a diagnostic center situated in said second remote location and capable of receiving transmitted diagnostic data from said eye examination location to enable the diagnosis of a eye disorder or disease of the patient by a medical
  • the eye examination may in some cases be any eye
  • a patient may be examined appropriate to the diagnosis of an eye condition (including the lack of a specific eye disorder) or disease related to the eye.
  • a patient may be examined appropriate to the diagnosis of an eye condition (including the lack of a specific eye disorder) or disease related to the eye.
  • a blood glucose detection device a blood pressure detecting device, a case history capture device, a lensometer, a tonometer, a visual fields tester, binocularity testing instruments; color vision testing devices; a fundus camera, retinal imaging device, a posterior segment imaging device, an automated refractor device, an optical coherence tomographer (OCT) device, a neural diagnosis device, a pupilometer, a scanning laser ophthalmoscope, a biomicroscope and a corneal topographer, and the like.
  • OCT optical coherence tomographer
  • an eye care professional such as an eye care professional, may be able to reasonably provide a competent professional opinion as to the presence, absence, or progress of the adverse retinal
  • the patient may be examined using two or more, or three or more, or four or more such medical examination devices .
  • the present invention is directed to a method of conducting a medical examination from a remote location, comprising using at least one medical diagnostic device at the medical examination location to provide patient examination data; wirelessly transmitting the medical
  • examination data to the examination location before the patient leaves the medical examination location; wherein the diagnostic center comprises no medical examination devices.
  • the present invention is directed to a method of conducting an eye examination from a remote location, comprising conducting an eye examination of a patient at an eye examination location using at least one eye examination device at the eye examination location to provide patient eye examination data; wirelessly transmitting the eye examination data to a diagnostic center remote from the eye examination location to enable a eye care professional located at the diagnostic center to communicate a professional opinion based on the transmitted eye examination data to the eye examination location in real time, preferably before the patient leaves the eye examination location; wherein the diagnostic center comprises no eye examination devices.
  • a "comprehensive eye examination” means an examination yielding patient data sufficient to reasonably support a professional opinion or professional recommendation by a medical professional for communication to the patient.
  • a comprehensive eye examination may require patient data obtained from at least two medical diagnostic devices, or at least three medical examination devices, or at least four medical examination devices.
  • a "comprehensive medical examination" means an
  • a comprehensive eye examination may require patient data obtained from at least two medical examination devices, or at least three medical examination devices, or at least four medical examination devices.
  • the wireless telecommunications device means a device such as a wireless cellular or satellite telephone capable of transmitting data (such as through a modem) , or a wireless mobile computing device such as, without limitation, a smartphone, a laptop computer, a personal digital assistant (PDA) , or a tablet computing device (such as, for example, an Ipad®-type device) capable of transmitting data over the internet or a digital telephone network, such as a 3G or 4G network.
  • the WTD is a general purpose WTD.
  • the wireless portable telecommunications device may have minimal microprocesssing ability itself, and is not capable of performing significant data processing; in such instances the WTD functions mainly as a means for wirelessly transmitting the collected data to a central computing site or cloud network.
  • the WTD is capable of processing the collected data to at least some extent prior to transmitting the data wirelessly; in such instances, the WTD may run software applications that are complementary to or adapted to function with the collection of data by a medical examination device .
  • software apps may be made to be run by an appropriate WTD to collect data from a medical examination device and permit additional patient/examination information to be input (either from the examination device, from a WTD data input means, or from an alternative source) such as one or more of the following items: the patient's name, age, sex, and/or any current medication; the date of the examination, the time of day of the examination, and other relevant
  • the WTD may contain and run a software application that collects patient examination data from a plurality of medical examination devices and may format the data for entry into a database.
  • this application may comprise a database itself, which may, for example, contain previous examination data from the same patient and may calculate comparisons test results over time.
  • the formatted data or updated database may be wirelessly transmitted directly to the diagnostic center, or may first be wirelessly transmitted to a central computing center or cloud computing network for further processing, for example using algorithms accessing previous medical data from the same patient or a database of medical information
  • the patient himself/herself may input data into a WTD device using a medical software
  • a patient who has diabetes may input such data as blood glucose, temperature, medications, carbohydrates ingested, and the like into an application stored in a WTD, which can then be transmitted to a remote location.
  • the medical examination devices may be the
  • thermometer blood glucose detecting means
  • blood glucose detecting means blood glucose detecting means
  • the medical examination devices used in the systems and methods of the present invention are at least partially integrated as part of the WTD wireless telecommunication device, or are directly connected to the wireless telecommunication device.
  • directly connected is meant that the medical examination devices are connected to the wireless telecommunication device either through a "wired” connection, such as a cable or port connection, or wirelessly, for example by use of Bluetooth® technology or other wireless transmission means.
  • Medical examination devices that may be connected to a wireless telecommunication device may comprise any device capable of converting the medical examination device data to digital form, and then relay the digital data to the wireless telecommunication device. Therefore, virtually any medical examination device including, for example and without
  • a MRI device a CT scan; a PET scan device; a mammography device; an echocardiogram device; an ultrasound device; an EMG device; a dual-emission X-ray absorptiometry device; X-ray devices; CRT devices; ultrasound devices; CAT scan devices; PET/CT scan devices; radiology devices; nuclear medicine scan devices, thermometers; EKG detecting devices; EEG detecting devices; blood pressure cuffs; still and motion picture cameras (including microscope cameras) ; blood glucose monitors; blood chemistry monitors; binocularity testing instruments; color vision testing devices; ophthalmic
  • ultrasound devices optical coherence tomographer (OCT) devices
  • OCT optical coherence tomographer
  • neural diagnosis device a pupilometer, a scanning laser ophthalmoscope, case history capture devices
  • lensometers lensometers; tonometers; visual fields testers; fundus
  • combinations of two or more such devices, and the like may be manufactured to have this capability.
  • combinations of two or more such devices, and the like may be manufactured to have this capability.
  • one or more of the medical examination devices are relatively simple and inexpensive, so as to permit their use in remote and sometimes undeveloped locations.
  • the data connection between the WTD and the medical examination device may be wireless; may comprise a digital cable capable of connecting with the WTD, and/or may comprise the ability of the device itself to be comprised as part of the WTD, for example, mounted on to or within the WTD, wherein the medical examination device data is related through a mounting
  • one or more medical examination device comprises a part of, attachment to, or extension of the WTD.
  • the medical examination device may comprise a slit lamp attachment, blood glucose monitor attachment, microscope attachment, spectrometer attachment, cataract detector attachment (such as the CATRATM system developed at MIT) , an abberometer attachment (such as the NETRATM system developed at MIT) , and similar devices either at least partially integrated as part of the WTD or as
  • attachments to the WTD used to examine a patient for one or more medical condition including the lack of any abnormal condition, disorder, or disease.
  • patient examination data may be collected from more than one type of medical examination device; for example, patient medical examination data may be collected by a WTD from standalone medical examination devices such as a PET scan device and transmitted either wirelessly or via data cable to the WTD; while other information concerning the same patient may be collected from medical examination devices that are integral to the WTD, such as a microscope attachment thereto.
  • the patient examination data collected by the medical examination devices is conveyed to and preferably stored by the WTD.
  • each item of patient examination data may be transmitted independently to a database in a remote location, either substantially as acquired or as formattd by an app comprised in the WTD. In either case, in a preferred embodiment of the present
  • the patient examination data is then wirelessly transmitted to a location remote from the patient examination location.
  • the patient examination data is wirelessly transmitted using a cellular telecommunications system, such as, without limitation, a 3G or 4G cellular mobile communications system.
  • a cellular telecommunications system such as, without limitation, a 3G or 4G cellular mobile communications system.
  • broadband access to wireless telecommunications may not be available; in such cases, the wireless transmission may occur by means of a modem which converts digital data from the WTD to an analog signal which may be transmitted over a telephone line.
  • This analog signal may be transmitted using non-broadband wireless
  • satellite telephone systems or even a wireless satellite telephone.
  • certain satellite telephone systems permit the transmission of digital data as well; additionally satellite-based internet access systems are known and used.
  • the wireless telecommunication system may wholly or partially comprise a local network, such as a hospital network system, the corporate network system, or a home computer network system.
  • Hospital or office-based network systems may comprise "Wi-Fi" transmitters that provide wireless telecommunications between the WTD and the internet as a whole at broadband speed.
  • the remote location may comprise a room or office in the same building the as patient examination location, or may be located at a site further away from the medical examination location .
  • the wireless telemedicine system of the present invention may comprise more than one patient examination location; for example a plurality of patient examination locations may each comprise medical examination devices and at least one WTD for transmission of patient examination data to a diagnostic center.
  • the patient examination data may be directly transmitted to the diagnostic center, or may be received at an intermediate location comprising, for example, a central computing center or cloud network in which the data may be stored and/or processed before being forwarded to the diagnostic center.
  • the central computing center or cloud network may be located at a site different from both the examination site and the diagnostic center, or may be located within the diagnostic center.
  • the central computing center may be comprised in a cloud network, or may be a computing center unconnected to a cloud network, such as a hospital, office or business computing center.
  • the wireless communication network and indeed all steps along the telecommunication link be suitable for the transmission of, for example, high resolution images, photographs, charts, test results and the like.
  • the wireless communication network and indeed all steps along the telecommunication link be suitable for the transmission of, for example, high resolution images, photographs, charts, test results and the like.
  • the wireless communications network and/or some of the intermediate steps may not support the
  • the wireless telemedicine system of the present invention in most cases will comprise a database in which patient examination information is stored. However in certain embodiments,
  • the patient examination data may be transmitted to the diagnostic center without intermediate long-time storage in a database, cloud computing network, or central computer center.
  • the WTD may itself calculate the refractive error data, and then wirelessly transmit this data via a telecommunications system directly to an optometrist or optician, who can provide a professional opinion based upon the patient examination data to prescribe the proper
  • the WTD itself may comprise a database, however, no database may be necessary between the patient examination site and the diagnostic center.
  • a central computing center or cloud network a database will generally be comprised as part of such a
  • the database may save and maintain records
  • the database may also add such information to previously existing data concerning the patient, and optionally format such data in a manner as a summary or report which can be sent or "pushed" to, or otherwise accessed by a medical
  • the database may be designed to enable collection of data from multiple patients, creation of statistics using the data contained therein and to analyze the data thereby allowing practitioner to search for and research population group trends, changes or expectations based on various criteria.
  • either or both the central computing center or cloud computing network and any data processing system at the diagnostic center may analyze the patient information according to one or more software-based medical algorithm.
  • Medical algorithms have been long developed as means by which a medical professional may acquire and process patient
  • a "professional opinion" may include such an indication of the need for further patient information.
  • the diagnostic center may be any location at which a medical professional is located, and where she may receive the patient examination data (either in a relatively raw format, or after analysis using a software-based medical algorithm) , and respond to the medical examination site with a
  • the diagnostic center may comprise, for example, a place of business, a physician's, nurse practitioner's, or midwife's home or office, a hospital or clinic, or any other location at which a medical professional is located can provide a professional opinion based upon the patient examination data and,
  • the diagnostic center comprises a computer system which saves the incoming patient examination information and/or analysis of such patient examination performed by any central computing center or cloud network.
  • the patient examination data may be displayed on an examination console for the medical professional so that she may formulate a professional opinion to be communicated back to the examination location;
  • the examination console may optionally be comprised as part of a WTD to which the medical professional has access, such as (without limitation) general purpose WTD such as a laptop computer, tablet computing device, or smartphone .
  • the examination console may be a desktop computer or terminal module part of a hospital, clinic, or doctor's office computer network; in still other cases more than one
  • examination console may be available, for example, as both a desktop computer and a tablet computing device.
  • the examination console may permit videoconferencing between the patient examination site and the diagnostic center.
  • videoconferencing may utilize cameras located on smartphones, tablet device or laptop computers running a software teleconferencing program, for example SkypeTM, FaceTimeTM, Go to MeetingTMor another videoconferencing software program.
  • a dedicated teleconferencing facility may be located and one or both the examination site or the diagnostic center.
  • the database if present at any step in the telecommunications link, is able to recall and display (or even compare) the patient examination data with the patient's medical history.
  • the patient's medical history may be entered during or attendant to the collection of the medical
  • the patient's medical history may include information based upon the patient's recollection (such as information gathered in a questionnaire during an initial visit to a new physician's office) and may include test results and patient examination data based upon one or more previous examination employing medical examination devices.
  • the patient's medical history may include charts, measurements, graphs, photographs, x-ray results, images from CAT scans or PET scans, as well as answers to questions posed in a medical questionnaire, such as previous illnesses, allergies, current medication, and the like.
  • the wireless telemedicine system of the present invention thus provides the ability for the medical professional to render a professional opinion based, at least in part, upon newly acquired patient examination data, and, in most cases, to provide a professional opinion via the wireless
  • telecommunications network to the patient examination site, preferably before the patient leaves the examination site.
  • software associated with computers at the diagnostic center, or the central computing center may be used to generate a printed report for the medical professional which includes a summary of the results of the patient
  • this report may be transmitted back to the patient or attending medical professional at the patient examination location for delivery to the patient upon completion of the examination.
  • the medical examination data, medical history, written reports, professional opinion and other transmitted patient data may be encrypted before transmission. Encryption and decryption of all patient data from points of transmission and data receipt ensures that the operators of the system maintain control and confidentiality in all aspects of patient care and communication.
  • the encryption may be applied to data before transmission through any of the communication links and/or before storage in the database; decryption may be performed by a software program residing on a computer or WTD at the point of data receipt, whether at the examination location, the diagnostic center, or at intermediate locations such as the central computer center or the cloud network.
  • a patient at an examination location (101) presents with suspected myopia.
  • the patient utilizes a general-purpose smartphone-based system for
  • the smartphone-based system comprises the use of a smartphone attachment (104) which is designed to work in conjunction with a software app comprised in the smartphone .
  • a smartphone attachment (104) By viewing a test screen through the smartphone attachment (104) the patient adjusts the display in the viewfinder using the manual
  • the software in the smartphone adjusts the viewfinder display in accordance with the
  • the smartphone calculates the refractive error for the eye used to view the display.
  • the smartphone calculates the refractive error in the patient's left and right eyes.
  • the patient examination data is then transmitted (109) by the cell site to the diagnostic center (111) .
  • the cell site (107) may wirelessly relay the patient examination data to one or more additional cell site, or may relay the patient examination data via a cable, such as fiber optic cable, either directly to the diagnostic center (111) or to another cell site (not shown) which then wirelessly transmits the signal to a display or terminal (113) at the diagnostic Center (111) .
  • the display or terminal (113) at the diagnostic center may comprise a simple viewing station, a desktop or laptop computer, or a WTD such as a tablet computing device.
  • the display or terminal (113) display is the patient examination data, or the results of the software program contained in the smartphone (103), which may comprise the calculated refractive error for each of the patient's eyes.
  • the displayed patient is transmitted (109) by the cell site to the diagnostic center (111) .
  • the cell site (107) may wirelessly relay the patient examination data to one or more additional cell site, or may relay the patient examination data via a cable, such
  • examination data may also include ROM measurements upon which the calculated refractive error depends for its conclusion so that the medical professional in the diagnostic center may verify the accuracy of the software calculation, or may make it an independent calculation herself.
  • the medical professional utilizes a telephone whose signal is transmitted (119) to a cellular tower (121) which then transmits the telephone call or
  • the medical professional at the diagnostic center may order the preparation of glasses
  • the time course of the example shown in Fig. 1 is sufficiently rapid to permit the medical professional at the diagnostic center to received the patient examination data, formulate a professional opinion, and communicate back to the remote examination location before the patient leaves the examination location.
  • the medical professional may be, without limitation, an ophthalmologist, an optometrist, a nurse, or an optician or other medical professional.
  • the examination location may use a satellite or dial-up modem-based system-particularly if the examination location is sufficiently remote, for example on board a ship or located in a rural or undeveloped area.
  • test for refractive error may be done using a traditional refracting device (such as an autorefractor) system, rather than a smartphone-based system, in which the data obtained using the system is conveyed to a WTD device, which then transmits the patient examination data in a manner substantially similar to that shown in Fig. 1.
  • a traditional refracting device such as an autorefractor
  • WTD device which then transmits the patient examination data in a manner substantially similar to that shown in Fig. 1.
  • a patient (203) at an examination location (201) is given two tests: an x-ray and blood pressure determination.
  • the x-ray machine produces an image (205) that is wirelessly transmitted (207) to a general purpose tablet WTD device (213) using, for example a Bluetooth wireless system.
  • a blood pressure cuff (209) produces a reading which is transmitted to the tablet device (213) via a data cable
  • the tablet WTD (213) displays the blood pressure data, the x-ray image, and medical history of the patient that has been manually entered into the WTD software (215) .
  • combined patient medical data is preferably encrypted and then transmitted wirelessly (217) to a cell site (219) which then relays (221) the patient medical data to a central computing center (223) .
  • the central computing center (223) may comprise a library of medical algorithms for different medical conditions. Based upon the patient's medical history, and the other patient examination data which it is received, combined with any other information concerning this patient that may reside within the database in the central computing center, the central computing center (223)
  • the computing center selects one or more medical algorithm with which it then tests the patient examination data.
  • the selection and testing procedures may be automatic, or may be manually initiated, either at the central computing site, by the patient or a medical professional at the examination location, or by a medical professional at the diagnostic center.
  • the algorithm (s) run by the central computing center (which may be a cloud computing network) may determine that there is insufficient data with which to formulate a professional opinion; this presumptive opinion is then transmitted (225) to a medical professional at the diagnostic center (227) and/or the examination location (201) so that the indicated additional information may be provided to permit the diagnostic algorithm to formulate a presumptive professional opinion. If the patient examination data, combined with the patient's medical history, is
  • the professional opinion and additional information, if any, is then displayed on a terminal or monitor at the
  • the terminal may be a terminal of a larger institutional computer network (such as a hospital, clinic, or medical office network) or may itself be a computer or WTD, such as a tablet computing device, such as an IPad® tablet, a laptop computer or a smartphone .
  • a larger institutional computer network such as a hospital, clinic, or medical office network
  • WTD such as a tablet computing device, such as an IPad® tablet, a laptop computer or a smartphone .
  • prospective diagnosis or professional opinion in this example may comprise a nested set of algorithms, in which a 1st algorithm is used to search a library of diagnostic algorithms and select one or more such diagnostic algorithms to run based the upon the patient examination data and any additional information provided either at the examination location, the diagnostic center, or elsewhere.
  • the diagnostic algorithms may be contained in a larger software program, in which a single software program algorithm is used to access, diagnose, and report a prospective professional opinion to the diagnostic Center.
  • particular diagnostic algorithms may be selected at the examination location or the diagnostic Center for use in processing the patient examination data, without the use of a larger multi functional diagnostic software program.
  • multi functional in this context is meant a larger software program capable of being used to diagnose a variety of different medical conditions.
  • the central computing center or cloud network may comprise a database containing additional information
  • the central computing center may contain the patient medical history, results of previous examination tests, and in certain cases comprises a collection of patient data from a plurality of patients which may be used for the creation of statistics using the data contained therein and to analyze the data, thereby allowing medical professionals to search for and research patient population group trends, changes or expectations based on various criteria.
  • the collection of patient data may be used to refine the diagnostic algorithms thereby providing
  • the algorithm or algorithms used to provide the prospective diagnosis may comprise a clinical decision support system (CDSS) .
  • CDSS is an active knowledge system, which uses two or more items of patient data to generate case-specific advice.
  • the methodology of using CDSS preferably forces the medical professional to interact with the CDSS utilizing both the medical
  • CDSS may make the diagnosis without human intervention, preferably the CDSS would make suggestions of outputs or a set of outputs for the medical professional to look through and the medical professional would pick useful information and remove
  • CDSS's generally comprise three parts, the knowledge base, inference engine, and a mechanism to communicate.
  • the knowledge base contains the rules and associations of compiled data which most often take the form of IF-THEN rules. For example, if the CDSS is used for determining drug
  • a rule might be that IF drug X is taken AND drug Y is taken THEN alert user.
  • an advanced user could edit the knowledge base to keep it up to date with new drugs.
  • the inference engine combines the rules from the knowledge base with the patient's data.
  • CDSS's that do not use a knowledge base use a form of artificial intelligence called machine learning, which allows computers to learn from past experiences and/or find patterns in clinical data.
  • machine learning Two types of non-knowledge-based systems are artificial neural networks and genetic algorithms.
  • Fig. 3 shows an example of a basic algorithm as an example of those which may be used in conjunction with the wireless telemedicine system of the present invention.
  • patient examination data is transmitted wirelessly from the examination location along with an indication of the reason for the medical examination. This latter information may be provided separately or may be inherently indicated in, or from the nature of, the patient examination data.
  • the algorithm may first inquire whether the patient's medical history is included with the patient examination data. If the patient medical history is not included with the patient examination data, then the algorithm may query whether the patient's medical history is on file within a database
  • the algorithm responds with a query, which may be sent to the diagnostic center and/or patient examination location in which, for example, a request for patient history information required to provide a prospective professional opinion
  • This query provides the medical professional at the examination location and/or the diagnostic location with an indication of what further patient history information should be provided before a prospective professional opinion may be rendered. If the patient medical history is included with the patient examination data, or if the patient medical history is currently on file within a database in an accessible computer center, then the medical history information is assessed for risk factors associated with the purpose for the current examination visit. If any such risk factors are present, they are readied for access by the medical diagnostic algorithm. Additionally (and not necessarily performed before the risk factor assessment is is made) a selection of one or more medical diagnostic algorithms pertinent to the medical reason for the patient's examination is selected. The medical diagnostic algorithm then compares the patient's examination data with the criteria requested by the selected algorithm or algorithms, as informed by the patient medical history. The algorithm or algorithms used for medical diagnosis assess the medical examination data to determine if there is sufficient examination data to formulate a professional opinion. If not, the necessary or desired additional examination data
  • the algorithm is/are performed using the patient examination data to answer queries at key algorithm decision points. After the algorithm has processed this information, if an opinion can be provided by the algorithm according to its criteria, then the
  • a medical professional at the diagnostic center receives output from the algorithm ( s ) , including the prospective professional opinion, if any.
  • the medical professional may optionally access the central computing center (or cloud network) computers to obtain further information if available or necessary in her opinion to help formulate a final
  • the medical professional then is able to telephone, teleconference with, and/or otherwise provide information back to a medical professional at the examination location or the patient, preferably before the patient leaves the examination location.

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Abstract

La présente invention concerne un procédé et système de télémédecine comportant au moins un dispositif de télécommunication sans fil (WTD), de préférence un dispositif de télécommunication sans fil universel, une pluralité de dispositions d'examen médical configurés pour l'acquisition de données médicales à partir du patient et acheminer les données vers le dispositif de télécommunication sans fil, et le dispositif de télécommunication sans fil transmettant les données d'examen de patient vers un centre de diagnostic éloigné. Le centre de diagnostic éloigné, un centre informatique central, ou un réseau infonuagique peut détenir une base de données de dossiers de patients correspondant aux données d'examen recueillies à distance, et peut exécuter des algorithmes de diagnostic pour assister un professionnel de la médecine se trouvant dans le centre de diagnostic pour fournir une opinion professionnelle basée sur les données d'examen au patient avant le départ du patient du site d'examen.
PCT/US2013/035644 2012-04-09 2013-04-08 Système de télémédecine sans fil WO2013155002A1 (fr)

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